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Product codes
ODE
Product code ODE
Device name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.1500
Review panel
GU
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.
Source
FDA openFDA device classification dataset
Related 510(k) Records
#
510(k), Device, Applicant table
510(k)
Device
Applicant
Decision date
K233240
GERDX-System
G-Surg GmbH
2024-06-21
K240879
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
Endogastric Solutions, Inc.
2024-04-26
K172811
EsophyX Z, EsophyX2 HD
Endogastric Solutions, Inc.
2017-10-19
K171307
EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories
Endogastric Solutions, Inc.
2017-06-22
K160960
EsophyX® Z Device with SerosaFuse Fasteners and Accessories
Endogastric Solutions, Inc.
2016-05-01
K151001
MUSE System
Medigus , Ltd.
2015-06-05
K143645
EsophyX® Z Fastener Delivery Device
Endogastric Solutions, Inc.
2015-03-04
K143634
MUSE System
Medigus , Ltd.
2015-01-20
K142113
ESOPHYX2 HD
Endogastric Solutions, Inc.
2014-09-30
K132151
SRS ENDOSCOPIC STAPLING SYSTEM
Medigus , Ltd.
2014-03-19
K120299
SRS ENDOSCOPIC STAPLING SYSTEM
Medigus , Ltd.
2012-05-18
K092400
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
Endogastric Solutions, Inc.
2009-11-06
K072125
ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
Ndo Surgical, Inc.
2007-10-18
K071553
ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
Ndo Surgical, Inc.
2007-09-18
K071651
EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES
Endogastric Solutions, Inc.
2007-09-14
K032820
MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
Ndo Surgical, Inc.
2003-10-23
K031262
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760
Ndo Surgical, Inc.
2003-05-23
K023234
ENDOSCOPIC PLICATION SYSTEM
Ndo Surgical, Inc.
2003-04-17
K003956
BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595
C.R. Bard, Inc.
2001-01-05
K994290
BARD ENDOSCOPIC SUTURING SYSTEM
C.R. Bard, Inc.
2000-03-20
Related GUDID Devices
#
Primary DI, Brand, Company table
Primary DI
Brand
Company
Published
00884450848135
SerosaFuse®
Merit Medical Systems, Inc.
2026-02-03
00884450848111
EsophyX® Z+
Merit Medical Systems, Inc.
2026-01-14
00884450848128
SerosaFuse®
Merit Medical Systems, Inc.
2026-01-14
00810275014011
SerosaFuse® Implantable Fastener Kit
ENDOGASTRIC SOLUTIONS, INC.
2019-03-14
00810275013052
SerosaFuse® 7.5mm Implantable Fastener Cartridges
ENDOGASTRIC SOLUTIONS, INC.
2019-03-13
00810275011089
EsophyX Z+
ENDOGASTRIC SOLUTIONS, INC.
2017-11-16
07290014036062
MUSE Endostapler
MEDIGUS LTD
2016-09-20
07290014036529
MUSE Console
MEDIGUS LTD
2016-09-20
00810275011065
EsophyX2 HD
ENDOGASTRIC SOLUTIONS, INC.
2015-10-24
00810275011072
EsophyX Z
ENDOGASTRIC SOLUTIONS, INC.
2015-10-24
00810275013014
6.5mm Cartridge
ENDOGASTRIC SOLUTIONS, INC.
2015-10-24
00810275013021
7.5mm Cartridge
ENDOGASTRIC SOLUTIONS, INC.
2015-10-24
00810275013038
6.5mm & 7.5mm Cartridge
ENDOGASTRIC SOLUTIONS, INC.
2015-10-24
07290014036079
MUSE Staple Cartridge
MEDIGUS LTD
2015-09-24